University of Iowa

Funding for Human Subjects Research:

DOE: Deputy Assistant Secretary for the Office of Health

$499,000.00 for: Fiscal Year 2006
DOE's fiscal (funding) year is 12/1/2005 to 11/30/2006.
Percent of funding associated with the use of human subjects: 100

Information on Use of Human Subjects:

This project does not involve the use of multiple protocols/subprojects.

Institutional Review Board (IRB) Review:
Type of Review: Full Board
Approving Institution: The University of Iowa
Most recent approval: 08/24/06
IRB approval number: 200008081; 200509719

Additional IRB approvals from other institutions:
Type of Review: Full Board
Approving Institution: Oak Ridge Associated Universities
Most recent approval: 05/07/02
Explanation of additional approval:
This project is also reviewed by a Central Beryllium Institutional Review Board, located at Oak Ridge Associated Universities. The purpose of this IRB is to review protocols and educational materials pertaining specifically to beryllium.

Number of human subjects who participated in this project/protocol/subproject in the last reporting period: 244
Reporting period for number of human subjects: Other: 12/01/05 to 11/30/06
Explanation:

The FY 2005-2006 is December 1, 2005 - November 30, 2006. Q18a indicates number of participants screened in the FY 2005-2006 from December 1 - October 5, 2006. Is it projected that at 80 more participants will be screened by November 30, 2006.

Type(s) of Human Subjects Involvement:

External use of ionizing radiation on human subjects:

• For diagnostic research

Collection of personally identifiable bodily materials (blood or blood products, urine, cells, tissue, teeth, organs, excreta, etc):

• Using bodily materials collected specifically for this project.

Use of personally identifiable data from questionnaires, surveys, or epidemiological studies:

• Using data collected from subjects specifically for this project.
• Using existing data that were collected for other purposes or projects.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

Since 2000, The University of Iowa College of Public Health has been conducting a medical surveillance program for individuals formerly employed at the Iowa Army Ammunition Plant (IAAAP) near Burlington, Iowa, who worked in atomic weapons manufacturing on what was known as Line 1. The Line 1 operations consisted primarily of atomic weapons assembly and disassembly and was functional from 1945 through 1975. In addition to fissionable or radioactive materials, these workers may have been occupationally exposed to potentially hazardous levels of a number of other toxic substances (explosives, solvents, epoxies, heavy metals, and fibrogenic dusts).

A similar medical surveillance program for another DOE site in Iowa, the Ames Laboratory at Iowa State University in Ames, Iowa, has been conducted since 2005. Such activities with the Ames Laboratory Former Workers involve cohort identification, education, risk stratification, targeted screenings, and claims assistance.

In 1939, the U.S. government asked leading scientists to join in a consolidated national effort to develop atomic energy. In order for a uranium fission chain reaction to be successful, tons of uranium metal needed to be produced with a purity far beyond what was commercially available.

In 1942, Iowa State University's Frank H. Spedding and subsequently Harley A. Wilhelm initiated a chemical research and development program to accompany the Manhattan Project's existing physics program. The Ames' group developed a process for producing nearly pure uranium, (removing virtually all impurities and decay products), making it possible to cast large ingots of uranium for nuclear reactor purposes. The Ames Project furnished one-third of the uranium metal used in the first successful demonstration of a chain-reacting pile at the University of Chicago.

Today, the Ames Laboratory pursues a broad range of applied research activities in chemical, materials, engineering, environmental, mathematical, and physical sciences under a variety of federal contracts.

Former workers will receive an occupational and health history questionnaire designed to collect general information on occupational duties and hazards at IAAAP and at the Ames Laboratory. Those who are determined to be eligible participants will be invited to receive a medical screening at no cost. Based on their work history, workers may receive some or all of the following procedures:
a. Spirometry
b. Laboratory tests: Blood and urine samples will be obtained for a series of screening tests which will include blood counts; liver, kidney and thyroid functions; blood sugar; and a urinalysis
c. Hemoccult fecal blood test ("stool card" kit) to screen for colon cancer
d. Beryllium Lymphocyte Proliferation Test (Be-LPT)
e. Chest X-ray: For those workers who receive chest X-rays, the amount of radiation involved is 6 mrem, or approximately equal to the amount of natural background radiation that the average American receives in one week.

Former workers will receive a written report of the results, appropriate educational materials, and if necessary, a referral to a primary care physician. Workers who no longer live near the screening site, or who prefer to be seen by their personal physician, will be referred to the DOE's National Supplemental Screening Program.

There may be no personal benefit for participating in this project. However, it is hoped that in the future society could benefit from this project by learning more about the relationship between workplace hazards and human health at the IAAAP, Ames Laboratory, and in other settings. Individuals may benefit from detection of early stages of treatable disease and furthermore may benefit from diagnostic information supporting and leading to successful worker compensation claims.

There is a risk of the emotional distress that some former workers may feel as a result of recalling and discussing prior exposures to toxic agents and possible subsequent health risks during the evaluations. An additional risk in this study is violation of confidentiality. Identity in this program will be treated as confidential. Although it is unlikely, confidential records may be disclosed only as provided by in the Privacy Act of 1974, the American with Disabilities Act (ADA), or as required by a court order or under other law.

The results of the examinations may be available to the people listed below. Some of these people may require access to records that identify workers by name:
1. The clinic staff members who provide the medical testing and who do the lab work
2. Medical specialists who provide or arrange for additional medical treatment or tests, if necessary
3. Staff from The University of Iowa who work for the Burlington Atomic Energy Commission Plant and the Ames Lab Former Worker Medical Screening Programs
4. Department of Labor staff who review the claims submitted to the Energy Employees Occupational Illness Compensation Program.
5. The University of Iowa Institutional Review Board (the committee that reviews and approves research studies) may inspect and copy records pertaining to this project
6. Others as required by the Americans with Disabilities Act, the Privacy Act of 1974, or as required by court order or under another law.

The University of Iowa project will protect confidentiality by assigning a unique number identifier that will be used in analyzing the information that we obtain. The code that matches names and numeric identifiers will be known only to the program's staff. Individually identified data will be kept in locked file cabinets at the University of Iowa. Any reports published as part of this research will refer to results only in the aggregate.

Information regarding medical and project information will be maintained in a database by The University of Iowa project staff for internal use only for the length of the project. This database will contain information such as name, social security number, address, age, work history, and diagnosis. Workers may request that personal information be removed from this database at any time by contacting the principal investigator or project coordinator.